Patient-reported Outcome Measures (PROMs) in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

Fibromyalgia Clinical Trial

— SYMPA  

Official title:

Patient-reported Outcome Measures (PROMs) as Characteristics and Prognostic Factors in Patients With Bodily Stress Syndrome: Protocol for a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04667611
• Other study ID #: 1159007
• Status: Recruiting
• Start date: March 9, 2020
• Est. completion date: December 2023

Study information

• Verified date: December 2020
• Source: Helsinki University Central Hospital
• Contact: Helena Liira, MD, PhD
• Phone: +358505771351
• Email: helena.liira[@]hus.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This cohort study implements patient reported outcome measures (PROMs) for patients with bodily stress syndrome in a clinic for functional disorders.

Description:

The Sympa Cohort study is a prospective, single site cohort study that consists of administration of PROMs questionnaires to patients that attend the Clinic for Functional Disorders at Helsinki University hospital (HUS). The questionnaires are handed out to the study population within seven days before their first visit at the clinic, and then at the following 3, 6 and 12 months. The study population consists of consecutive adult patients that are referred to the clinic either from other hospital units or primary care. The collected data will later be linked with national registries on diagnoses, medication use and work ability. The Sympa Cohort study may have implications in targeting the factors influencing functional outcomes and quality of life reported by patients with bodily stress syndrome. It will also form a quality register for the Clinic and characterize the first systematic collection of PROMs related to these disorders in Finland.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All genders

• Age 18-80 years

• Referred to Clinic for Functional Disorders either from other hospital units or from primary care

• Willingness to be enrolled in the study, by signing the informed consent

Exclusion Criteria:

• Patients not able to fill in the forms in Finnish or due to physical constraints (e.g. dystonia)

• Symptoms are likely due to a somatic disorder

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Dysphagia
• Exhaustion; Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Irritable Bowel Syndrome
• Medically Unexplained Symptoms
• Somatic Symptom
• Syndrome

Intervention

Behavioral:
• Psychosocial interventions
Cognitive behavioural therapy (CBT) based individual and group intervention

Locations

Country	Name	City	State
Finland	Clinic for Functional Disorders, Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-rated global health improvement	Measured by clinical improvement scale (clinical global improvement, CGI), a five-point Likert scale	12 months
Primary	Functional ability	Measured by WHODAS 2.0	12 months
Secondary	PHQ-9	Depression	3, 6 and 12 months
Secondary	GAD-7	Anxiety	3, 6 and 12 months
Secondary	EUROHIS-QOL-8	Health related quality of life	3, 6 and 12 months
Secondary	15D	Health related quality of life	3, 6 and 12 months
Secondary	SSD-12	Symptom severity	3, 6 and 12 months
Secondary	RS-14	Resilience	3, 6 and 12 months